Black Triangle Scheme

This section provides information about reporting suspected adverse drug reactions for healthcare professionals. Information for patients is available in the 'Patient reporting of suspected adverse drug reactions' section (please see 'Related information on the right of this page').

When medicines come onto the market, we have relatively limited information about their safety from clinical trials. New medicines are therefore intensively monitored in order to confirm the risk/benefit profile. The Commission on Human medicines (CHM) and the MHRA encourages the reporting of all suspected reactions to newer drugs and vaccines - products that are indicated by the inverted black triangle symbol.

What are black triangle drugs?
Black triangle products are new drugs and vaccines which are being intensively monitored in order to confirm the risk/benefit profile of the product.

A black triangle symbol indicates that the CHM and MHRA are intensively monitoring that product.  This will be indicated against a product:

  • in the 'British National Formulary' (BNF);
  • in the 'British National Formulary for Children' (BNFC);
  • in the 'Nurse Prescribers' Formulary' (NPF);
  • in 'MIMS'; 
  • in the 'ABPI Medicines Compendium'; and
  • on advertising material.

A black triangle is assigned to a product if the drug is a new active substance. However, a product containing previously licensed active substances may also be monitored if it meets one or more of the following criteria:

  • a new combination of active substances;
  • administration via a new route of administration or drug delivery system;or
  • a significant new indication which may alter the established risk/benefit profile of that drug 

There is no standard time for a product to retain black triangle status. However, an assessment is usually made following two years of post-marketing experience and the black triangle symbol is not removed until the safety of the drug is well established.

Why do we monitor black triangle drugs?
The CHM/MHRA wish to receive all reports of suspected adverse reaction associated with these products in order:

  • to confirm the risk/benefit profile established during the pre-marketing phase; 
  • to increase our understanding of the safety profile of new medicines; and
  • to ensure that we identify previously unrecognised side effects as quickly as possible.

When new medicines come on to the market, we have only limited information about their safety. The new medicine will have been tested in clinical trials. However, these trials generally involve only small numbers of patients who take the medicine for a relatively short period of time, and there are strict conditions for the inclusion of patients in such trials.

This means that the patients in whom the medicines are tested may not be fully representative of the patients who will use the medicine when it is marketed. In addition, it is not until large numbers of patients have taken a drug that we can detect side effects which are rare or which appear after long-term use.

Close monitoring of new medicines once they are being more widely used in the general population enables us to identify such side effects and take appropriate action.
The CHM/MHRA encourages the reporting of all serious suspected reactions to established drugs and vaccines, even if the effect is well known.

For specific black triangle enquiries please contact us at blacktriangle@mhra.gsi.gov.uk

Current drugs under intensive surveillance (Black Triangle List)
› Drugs under intensive surveillance (Black Triangle List): Generic names - November 2008 (102Kb)
› Drugs under intensive surveillance (Black Triangle List): Trade names - November 2008 (106Kb)

Previous drugs under intensive surveillance (Black Triangle List)


Page last modified: 12 November 2008